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临床试验/NCT04186325
NCT04186325招募中不适用

Ultrasound Assessment of Diaphragmatic Muscle Exercise in Mechanically Ventilated Patients.

Mansoura University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年12月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
the incidence of diaphragmatic muscle atrophy

研究概览

简要总结

Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult.

Mechanical ventilation after endotracheal intubation predisposes these patients to an increased incidence of pulmonary complications such as ventilator-associated pneumonia (VAP), increased risk of deep vein thrombosis, bedsores, increased hospital stay, and poor clinical outcome.

The weaning process from MV involves the reduction of ventilator parameters and Extubation. Daily, careful evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the MV.

The diaphragm which is the principal respiratory muscle provides nearly 75% of the resting pulmonary ventilation. However, In ICU patients, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis. Diaphragmatic dysfunction and atrophy is the main precipitating factor for difficult and successful weaning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients attached to mechanical ventilation will be included in the study after the informed consent of the legal guardian.

排除标准

  • Patients with severe acute lung injury, morbid obesity, chest wall deformity, direct diaphragmatic injury, cervical spine and patients who require neuromuscular infusion will be excluded from the study.

研究组 & 干预措施

Group C

No Intervention

Group C: the regular mechanical ventilation protocol will be followed.

Group T

Experimental

Group T: inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.

干预措施: DIAPHRAGMATIC exercising (Procedure)

结局指标

主要结局

the incidence of diaphragmatic muscle atrophy

时间窗: seven mechanical ventilation days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

maha abou-zeid

lecturer

Mansoura University

研究点 (2)

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